Location: Gurugram, India
Company: Syneos Health
Job ID: 25104831
Experience Required: 10–15 years (Senior leadership role – Not suitable for freshers)
About the Company
Syneos Health is a globally established, fully integrated biopharmaceutical services organization dedicated to accelerating clinical development and commercialization. With a strong global footprint and expertise across the drug lifecycle, the organization partners with pharmaceutical and biotech innovators to deliver high-impact healthcare outcomes.
Role Overview
The Associate Director – Safety & Pharmacovigilance (PV) is a senior leadership position responsible for overseeing end-to-end safety operations, managing cross-functional teams, and ensuring regulatory compliance across global pharmacovigilance programs. This role demands strategic oversight, client engagement, and operational excellence in safety surveillance and reporting.
Key Responsibilities
Leadership and Team Management
Provide line management to Safety and Pharmacovigilance teams, including hiring, training, performance management, and career development
Drive team productivity, quality standards, and delivery excellence across multiple projects
Operational Oversight
Lead and manage global pharmacovigilance projects, ensuring adherence to Safety Management Plans and regulatory requirements
Monitor project performance, timelines, budgets, and deliverables
Act as the primary escalation point for sponsors and stakeholders
Stakeholder and Client Management
Serve as the key interface between sponsors, vendors, and internal departments
Provide strategic guidance to clients on safety-related issues and regulatory expectations
Lead client meetings, project updates, and bid defense presentations
Quality and Compliance
Ensure compliance with global regulations including ICH-GCP, GVP modules, and applicable safety reporting requirements
Participate in audits, inspections, and quality investigations
Oversee SOP development, process optimization, and continuous improvement initiatives
Financial and Business Strategy
Review and manage study budgets, invoicing, and financial performance
Collaborate with Business Development teams for proposal development and new business acquisition
Support resource planning and allocation for pharmacovigilance services
Scientific and Safety Oversight
Review clinical safety sections of study protocols and CRFs
Ensure consistency and accuracy in Serious Adverse Event (SAE) reporting processes
Oversee safety data review, reporting timelines, and issue resolution
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or related healthcare field
10–15 years of experience in Pharmacovigilance, Drug Safety, or Clinical Research
Proven leadership experience in managing global safety teams and large-scale PV programs
Strong knowledge of ICH-GCP, GVP, regulatory frameworks, and safety databases
Experience in CRO environment preferred
Key Skills
Strategic leadership and decision-making
Advanced stakeholder and client management
Budgeting and financial oversight
Strong communication and presentation skills
Ability to manage multiple priorities in a fast-paced, matrix environment
Why This Role Matters
This is a high-impact leadership opportunity to drive global pharmacovigilance operations, influence drug safety strategies, and contribute to patient safety on a global scale. You will work at the intersection of science, compliance, and business, shaping the future of drug safety.
Important Note for Applicants
This is a senior-level leadership role requiring extensive experience in pharmacovigilance and team management. Freshers and entry-level candidates should consider roles such as Drug Safety Associate, PV Associate, or Safety Specialist to build foundational experience before progressing to leadership positions.
How to Apply
Apply through the official careers page of Syneos Health or explore more verified global pharmacovigilance jobs on ThePharmaDaily.com
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